Kornimate/medical-research-clean huggingface dataset:
using trap to evaluate the effect of zometa on bone metastasis due to lung cancer

Conditions: Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung; Metastases

Summary: the purpose of this study is to evaluate a new blood test as a way to follow the effect of zometa in treating bone metastases due to lung cancer.

the purpose of this research study is to evaluate a new blood test as a way to follow the effect of zometa in treating bone metastases. the blood test will look for a protein, called trap, which is released into the blood stream by the breakdown of bone. this study will compare the trap blood test with other blood tests for bone destruction.

Eligibility criteria:
inclusion criteria: * invasive lung cancer (small cell or non-small cell lung cancer) * osteolytic bone metastasis determined by clinical exam, bone scan/xr * age \> 18 years exclusion criteria: * concurrent malignancy with a second primary * renal failure (serum creatinine \> 3mg/dl) * pregnancy * active rheumatoid arthritis * intolerance to zoledronic acid

Keywords: zometa bone metastasis lung cancer non-small cell lung cancer small cell lung cancer bone metabolic markers tartrate resistant acid phosphatase
evaluation of the oncoral® test in epidermoid carcinomas of the upper aerodigestive tract

Conditions: Carcinoma

Summary: this is a multicentric feasibility study aimed to evaluate the oncoral® test. the study includes 2 steps. the first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. patients will be enrolled before any treatment. they will immediately undergo the test. no follow-up will be realized. in total, 100 patients will be included in this first step. the estimated period of inclusion is 6 months. if the algorithm is validated, the second step of the study will start. the purpose is to determine the characteristics of the test. enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. in total, 385 patients will be enrolled in this step during an estimated period of 18 months.


Eligibility criteria:
inclusion criteria: first step: * man or woman aged more than 40 years * with frequent alcohol intoxication and/or smoking * with histologically confirmed epidermoid carcinoma of the upper aerodigestive tract * no treatment delivered for this disease * signed, written informed consent * mandatory affiliation with a health insurance system second step: * man or woman aged more than 40 years * with frequent alcohol intoxication and/or smoking * with no sign of an epidermoid carcinoma of the upper aerodigestive tract * signed, written informed consent * mandatory affiliation with a health insurance system exclusion criteria: first step: * previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent * gingivorrhagia when the test is realised * hypersensitivity to aspirin or to benzoate * asthmatic, diabetic patients or patents with chronic bronchitis requiring oxygen therapy * patients taking antibiotics at enrolment or during the previous week second step: * previous history of cancer except carcinoma in situ of the uterine cervix or skin basal cell carcinoma treated with curative intent * patient already treated for a cancer * gingivorrhagia when the test is realised * hypersensitivity to aspirin or to benzoate * asthmatic, diabetic patients or patients with chronic bronchitis requiring oxygen therapy * patients on antibiotics at enrolment or during the previous week

Keywords: otolaryngology
risk factors and complications contributing to mortality in elderly patients with fall-induced femoral fracture

Conditions: Femoral Fractures

Summary: this study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level.

this retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who were admitted into a level i trauma center, between january 1, 2009 and december 31, 2017. multivariate logistic regression analysis was performed to identify independent effects of univariate predictive variables on the occurrence of mortality.

Eligibility criteria:
inclusion criteria: * patients with a fall from ≥1 m as well as those for whom incomplete data were available. exclusion criteria: * those patients with a fall from ≥1 m * patients with incompleted data

Keywords: femur fracture trauma fall elderly mortality respiratory complication
resolute japan svs: the clinical evaluation of the mdt-4107 des in the treatment of de novo lesions in small diameter native coronary arteries

Conditions: Arterial Occlusive Diseases; Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease

Summary: the objective of the study is to verify the safety and efficacy of the mdt-4107 drug-eluting coronary stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (rvd) that allows the use of 2.25mm diameter stents.

the objective of the study is to verify the safety and efficacy of the mdt-4107 drug-eluting coronary stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (rvd) that allows the use of 2.25mm diameter stents.

Eligibility criteria:
inclusion criteria: * acceptable candidate for percutaneous coronary intervention (pci),stenting, and emergency coronary artery bypass graft surgery * clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study * informed consent * patient agrees to comply with specified follow-up evaluations at same investigational site * single target lesion or two target lesions located in separate coronary arteries * de novo lesion(s) in native coronary artery(ies) * target lesion(s) ≤ 27 mm in length * target vessel(s) have reference vessel diameter 2.25 mm to 3.5 mm exclusion criteria: * within 7 days of implant platelet count \ 700,000 cells/mm³; white blood cell (wbc) count \ 2.5 mg/dl * acute myocardial infarction (mi) within 72 hrs of the index procedure (q wave myocardial infarction(qwmi)/non q wave myocardial infarction (nqmi) or any elevation of creatinine kinease myocardial-band isoenzyme(ck-mb) \> lab upper limit of normal) * previous pci of target vessel(s) within 9 months prior to the procedure * planned pci of any vessel within 30 days post-index procedure and/or planned pci of target vessel(s) within 12 months post-index procedure * history of stroke or transient ischemic attack(tia) within prior 6 months * participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints * inability to comply with required trial antiplatelet regimen * previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent * target vessel(s) has/have other lesions w/ \> 40% diameter stenosis * unprotected left main coronary artery disease

Keywords: medtronic japan arterial occlusive diseases myocardial ischemia cardiovascular diseases coronary artery disease small vessel stent
bio-significance of lpc16:0 in fibromyalgia

Conditions: Fibromyalgia, Primary; Pain; Soreness, Muscle; Oxidative Stress; Metabolomics; Lipidomics

Summary: fibromyalgia (fm) is a very common but mysterious pain disorder characterized by chronic widespread muscular pain. fatigue, anxiety and depression are common comorbidities. the syndrome is commonly associated with several symptoms, including fatigue, sleeping disturbance, cognitive impairment, and comorbid pain syndrome, especially irritable bowel symptoms and temporomandibular disease. anxiety and depression are common psychiatric co-morbidies. daily stress is believed to trigger or aggravate pain conditions. these symptoms can markedly affect patients' quality of life, and even lead to disability. so far, the etiology and pathogenesis are largely unknown, and diagnostic biomarkers and curative treatment remain to be developed. recent technological advances enable scientists to explore mechanisms by genetic, transcriptomic, proteomic, and metabolomic researches. however, no definitive result has been concluded for clinical practice so far. in this study, the investigators use tailored questionnaires to evaluate fibromyalgia and associated symptoms, including numeric rating scale for soreness, widespread soreness index, fibromyalgia impact questionnaire, hospital anxiety and depression scale, and perceived stress scale. the investigators also use metabolomics and lipidomic approach to probe the potential pathophysiology of fibromyalgia. in our prior translation research (pmid: 32907805), the investigators found that excessive lpc16:0 resulting from lipid oxidization inflicts psychological stress-induced chronic non-inflammatory pain via activating asic3. in this content, our prior translational research identified a potential nociceptive ligand that causes fibromyalgia symptoms, which is likely to function as biomarkers for diagnosis or disease monitor. in the current clinical investigation, the investigators aim to reversely translate the novel findings in animal studies and validate the bio-significance of lpc16:0 for fibromyalgia with clinical approaches.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of fibromyalgia exclusion criteria: 1. systemic rheumatological or immune disorders (e.g., systemic lupus erythematosus, inflammatory myositis), 2. systemic use of corticosteroids, 3. pregnancy, 4. chronic diseases under poor control 5. malignancies.

Keywords: lysophosphotidylcholine fibromyalgia pain soreness metabolomics
the effects of cognitive dual-tasking in later stages of rehabilitation after acl reconstruction

Conditions: Anterior Cruciate Ligament Reconstruction; Athrogenic Muscle Responses; ACL Injury

Summary: anterior cruciate ligament (acl) injuries are common in sports and often require a long and challenging rehabilitation process. athletes who sustain these injuries typically engage in pivoting and cutting sports, where these motor tasks must be performed simultaneously with cognitive tasks such as decision-making and keeping an eye on the opponent. directing attention to both cognitive and motor tasks leads to cognitive-motor interference, which is associated with movement patterns that increase the risk of acl (re)injury. therefore, it is crucial that before returning to such demanding sports after acl reconstruction, athletes sufficiently develop and automate safe yet efficient motor skills to free up attentional capacity for decision-making, thereby reducing the risk of suboptimal movement patterns and reinjury. however, current rehabilitation programs often primarily focus on the motor component in a single-task manner, giving insufficient attention to the cognitive component that is inseparable from sports. this randomized controlled trial aims to investigate the effects of implementing motor-cognitive dual tasks in the end phase rehabilitation after acl reconstruction on muscle function, functional outcomes, and patient-reported outcomes.


Eligibility criteria:
inclusion criteria: * 18-40 years old. * having suffered an acl rupture. * undergoing a surgical acl reconstruction in the az delta hospital in roeselare (campus brugsesteenweg). exclusion criteria: * revision acl reconstruction. * other severe injuries to the lower limbs within the past year. * muscle or neurological disorders affecting lower limb functioning. * fibromyalgia or chronic fatigue syndrome.
study to investigate the feasibility and safety of a dedicated high resolution nuclear breast imaging camera

Conditions: Breast Cancer

Summary: to evaluate the feasibility, acceptability and safety of using a molecular breast imaging (mbi) gamma camera in women at high risk of developing breast cancer


Eligibility criteria:
inclusion criteria: * females ≥18 years of age * undergoing annual breast mri because of a high risk of breast cancer due to any of the following: * known brca1 or brca2 mutation carriers, or is untested for brca but is a first degree relative of a brca mutation carrier * history of radiation to the chest between 10-30 years of age (e.g. hodgkin's disease) * history of cowdens or li fraumeni syndrome * a first degree relative with cowdens or li fraumeni syndrome * prior breast biopsy positive for lobular carcinoma in situ (lcis) or atypical lobular hyperplasia or atypical ductal hyperplasia (adh) * family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the ibis risk evaluator exclusion criteria: * pregnant or lactating * history of invasive breast cancer or ductal carcinoma in situ (dcis) * unable to undergo mri because of: * renal dysfunction with an estimated creatinine clearance of \< 30 ml/min calculated using the cockcroft-gault formula * implanted ferrous metal prostheses * claustrophobia * medical or psychological conditions that on assessment, make them unable to complete the procedure * known allergies to gadolinium-dtpa * known allergies to sestamibi (miraluma or cardiolite) * prior bilateral mastectomy * prior breast biopsy or surgery within 3 months

Keywords: breast cancer molecular breast imaging mri gamma camera
safety, tolerability and pk study of methylphenidate hcl erct in 4-5 year old children with adhd.

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: 2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate hcl erct in 4-5 year old children with adhd.

phase 4, open-label, safety, tolerability and pharmacokinetic study of methylphenidate hydrochloride (hcl) extended release chewable tablets (erct) in 4-5 year old children with attention deficit hyperactivity disorder (adhd)

Eligibility criteria:
inclusion criteria: 1. male or female child 4-5 years of age at screening. 2. signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable) 3. meets dsm-5 criteria for adhd based on the k-sads-pl. 4. adhd rs-iv preschool-home version score at screening and baseline \>/= 90th percentile for gender and age in \>/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score. 5. peabody picture vocabulary test 4 (ppvt-4)standard score \>/=70. 6. child global assessment scale (cgas) score \</= 55. 7. history of an adequate course of non medication treatment for adhd based on investigator judgment or, where such treatments are not available, the severity of the subject's adhd symptoms are such that medication treatment is deemed necessary by the investigator. exclusion criteria: 1. treated with atomoxetine within 30 days prior to the baseline. 2. received any investigational products or devices within 30 days prior to the baseline visit. 3. history of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant.if a subject has a known allergy to d\&c red #30, he/she should not be enrolled in the study. 4. an intelligence quotient (iq) \<70. 5. history of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality. 6. less than 5th percentile for height or weight at screening. 7. history of recent clinically significant self-harming behaviors.
probiotics for chalaziosis treatment in children

Conditions: Chalazion

Summary: there is growing evidence encouraging the use of probiotics in many conditions in children. the aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.

prospective comparative pilot study on 26 children suffering from chalaziosis. they will be randomly divided in two groups. one group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. all patients will be evaluated at 2-week intervals for 3 months. if the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. the follow up periods extend from 3 to 6 months according to the results.

Eligibility criteria:
inclusion criteria: * paediatric patients * presence of one or more eyelid mass lesions (history of rapid onset of painful inflamed mass that had reached a stationary size for more than 2 months) exclusion criteria: * eyelid infection * chalazion duration \< 1 month * nonpalpable chalazion * suspicion of malignancy

Keywords: microbiome/microbiota probiotics chalaziosis children
a study of subcutaneous risankizumab injection for pediatric participants with moderate to severe plaque psoriasis to assess change in disease symptoms

Conditions: Psoriasis

Summary: psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. there is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. this study will assess the change in disease symptoms. risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. this study has 4 parts. part 1: participants aged 12 \< 18 will receive a fixed dose of risankizumab. part 2: participants aged 12 \< 18 will receive; * period a: risankizumab or ustekinumab based on body weight followed by; * period b: risankizumab or no treatment. * period c: re-treatment with risankizumab (if needed). part 3: participants aged 6 \< 12 will receive risankizumab based on body weight. part 4: participants aged 6 \ 18 will receive risankizumab based on body weight). around 132 participants will be enrolled in approximately 50 sites worldwide. risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection. parts 1, 3, and 4: risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks. part 2: * period a: risankizumab or ustekinumab for 16 weeks. * period b: risankizumab or no treatment for 36 weeks. * period c: re-treatment with risankizumab for 16 weeks. follow-up call 20 weeks later for a study duration of approximately 81 weeks. participants from each part who meet eligibility criteria for an open-label extension (ole) study may continue on risankizumab for 216 additional weeks. there may be a higher burden for study participants compared to standard treatment. participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit. * stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (bsa) psoriasis involvement and scores on the psoriasis area and severity index (pasi) and static physician global assessment (spga). * candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the screening and baseline visits per the protocol. exclusion criteria: - concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.

Keywords: plaque psoriasis risankizumab ustekinumab psoriasis biologic abbv-066 skyrizi
cbd knee scope study

Conditions: Post-operative Pain

Summary: this is a prospective, randomized, nonblinded trial to evaluate the effectiveness of cannabidiol (cbd) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.

this is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. the first group will receive the soc opioid course: 7 days of percocet (oxycodone 5mg-acetaminophen 325mg) every four hours po prn, following surgery. the second 100 mg cbd daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg cbd daily for 30 days pre-operatively continuing 30 days post-operatively. all subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. they will only differ in pre-operative pain medication administration if they are in one of the two cbd groups. the groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). sleep quality will be assessed with the insomnia severity index (isi) while pain, need for refill, and switch to opioids will be recorded by the patient on crf packets. the crf packets will be given to patients at each visit for them to fill out to the best of their ability.

Eligibility criteria:
inclusion criteria: * age 18 or older * requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury * able to complete surveys and follow-up visits exclusion criteria: * younger than 18 years of age * history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, \*pregnancy.
clozapine hematological monitoring regulatory compliance assessment in psychiatry

Conditions: Schizophrenia; Agranulocytosis

Summary: clozapine is a drug that requires regular and diligent hematological monitoring throughout its use. this follow-up is, in france, framed by a compulsory paper format of the blood count follow-up notebook for each patient. due to the multiplicity of the different modes of transmission of the different documents necessary for compliance with the regulations for the prescription, dispensing and administration of clozapine, we decided to carry out a current inventory in the department of loire with respect for the latter. the main objective of this study is to assess the rate of non-compliance in circuits of prescription, dispensing and administration of clozapine by sending a questionnaire on habits of prescriptions, dispensing and administration of health professionals (psychiatrists, pharmacists), and by sending a questionnaire to the patients treated by clozapine.


Eligibility criteria:
inclusion criteria: * population 1: all patients stabilized of medical-psychological center (cmp) of st-etienne treated with clozapine * population 2 : all psychiatrists of the loire department * population 2 : all pharmacists of the loire department exclusion criteria: na

Keywords: clozapine schizophrenia hematological monitoring agranulocytosis regulation paper tracking book